BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OraQuick HCV Rapid Antibody Test

    Reg #: 3003297763 · FEI: 3003297763 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ORASURE TECHNOLOGIES, INC.
    Registration Number
    3003297763
    FEI Number
    3003297763
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    150 WEBSTER ST
    City
    Bethlehem
    State
    PA
    ZIP
    18015
    Country
    US

    Regulatory Submissions

    PMA Number
    P080027

    Owner / Operator

    Firm Name
    ORASURE TECHNOLOGIES, INC.
    Operator Number
    9000083
    Address
    220 EAST FIRST STREET, --
    City
    Bethlehem
    State
    PA
    Postal Code
    18015
    Country
    US
    Correspondent
    Tiffany A Miller

    Products

    Device Name Product Code
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus MZO

    Proprietary Names

    OraQuick HCV Rapid Antibody Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility